A Regulatory Earthquake
If you've tried to obtain peptides through a compounding pharmacy in 2025, you've likely encountered a dramatically different landscape. FDA guidance changes have restricted the compounding of numerous popular peptides, affecting patients, clinicians, and the compounding industry alike.
Understanding the Regulatory Framework
503A vs. 503B Pharmacies
The FDA distinguishes between two types of compounding facilities:
503A Pharmacies (Traditional Compounding):
- State-licensed
- Compound based on individual prescriptions
- Patient-specific preparations
- Subject to state boards of pharmacy
503B Outsourcing Facilities:
- Federally registered
- Can compound without individual prescriptions
- Batch production for office use
- Subject to CGMP requirements and FDA inspection
The Bulk Drug Substance System
Both 503A and 503B facilities must use approved bulk drug substances. FDA evaluates substances and places them in categories:
Category 1: Can be compounded (FDA won't take action) Category 2: Safety risks identified (cannot compound) Category 3: Insufficient evidence for evaluation (cannot compound)
The January 2025 Changes
In January 2025, FDA released guidance that significantly impacted peptide availability:
Key Changes
-
New nominations frozen: Substances nominated after January 7, 2025, won't be placed in interim categories
-
Stricter interpretation: 503A pharmacies can only compound substances that:
- Are in FDA-approved drugs
- Have USP monographs
- Are in Category 1 of the bulks list
-
No pathway for many peptides: Substances without monographs (like most research peptides) cannot be compounded until FDA completes review—which may never happen
Peptides That CAN Still Be Compounded
Category 1 / Approved Substances
- NAD+
- Sermorelin (with restrictions)
- Certain FDA-approved peptide drugs
Substances with USP Monographs
- Some established peptides have pharmacopeia standards
- These can generally be compounded
Peptides That CANNOT Be Compounded
As of current guidance, these popular peptides are effectively off-limits:
- BPC-157: No approval, no monograph
- Thymosin Alpha-1: Despite approval in other countries
- TB-500 (Thymosin Beta-4 fragment): Research-only status
- CJC-1295: No FDA approval
- Ipamorelin: No FDA approval
- AOD-9604: No FDA approval
- GHK-Cu (injectable): No monograph for injection
- Melanotan II: No approval
- KPV: No approval
- Selank: No FDA approval
- Semax: No FDA approval
The Semaglutide Situation
GLP-1 drugs illustrate the complexity:
Background
During semaglutide shortages, FDA exercised enforcement discretion, allowing compounding.
2025 Changes
FDA determined semaglutide shortages resolved:
- 503A enforcement discretion ended April 22, 2025
- 503B discretion ended May 22, 2025
- Compounded semaglutide now restricted
Ongoing Litigation
Multiple lawsuits challenge FDA's shortage determination and compounding restrictions. The outcome could affect other peptides.
The Biologics Distinction
The 40-Amino Acid Line
- Peptides: <40 amino acids
- Biologics: ≥40 amino acids
Why It Matters
Biologics require a biologics license. 503A facilities cannot obtain biologics licenses, meaning:
- Longer peptides are completely off-limits
- Some "peptides" are actually biologics
- This isn't negotiable
Impact on Patients and Clinics
Patients
- Lost access to established treatments
- Forced to discontinue protocols
- Facing higher costs for FDA-approved alternatives (if they exist)
Clinics
- Legal liability concerns
- Treatment protocol disruptions
- Patient communication challenges
Compounding Pharmacies
- Reduced revenue streams
- Regulatory compliance costs
- Some facilities closing
Legal Challenges
Industry Pushback
Compounding industry groups and some clinicians argue:
- FDA overreach beyond statutory authority
- Inadequate evidence for some restrictions
- Harm to patient access
Litigation Status
Multiple legal challenges are working through courts. Outcomes could:
- Clarify FDA authority
- Potentially restore some compounding options
- Establish precedents for future substances
What This Means Going Forward
Short-Term
- Many peptides unavailable through legal US channels
- Gray market likely to grow
- Quality and safety concerns increase
Medium-Term
- Legal challenges may reshape landscape
- Some peptides might achieve FDA approval
- Industry consolidation likely
Long-Term
- Possible new regulatory frameworks
- International options may become more common
- Black market risks continue
Options for Those Seeking Peptides
Legal Options
- FDA-approved drugs: Where available (e.g., tesamorelin, certain GLP-1s)
- Clinical trials: Access through research participation
- International treatment: Countries where peptides are approved
Gray Market Reality
Many will turn to:
- Online research chemical vendors
- International sources
- Unregulated suppliers
Caution: This carries real risks:
- Unknown purity
- Contamination
- No quality control
- Legal exposure
Conclusion
The 2025 FDA guidance changes have fundamentally altered peptide access in the United States. Whether through clinical necessity, business interests, or personal choice, many people are affected by these restrictions.
The regulatory intention—protecting public health from unproven compounds—conflicts with the reality that many patients and clinicians have used these peptides for years. How this tension resolves will shape the future of peptide medicine in America.
For now, the landscape is clear: most popular peptides cannot be legally compounded in the US. Understanding this reality is the first step in navigating what comes next.
This article is for educational purposes only. Consult legal and medical professionals for guidance on specific situations.